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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name manual antimicrobial susceptibility test systems
510(k) Number K240445
Device Name The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.
Thermofisher Scientific
1 Thermofisher way
Oakwood Village,  OH  44146
Applicant Contact Joel Mathew
Thermo Fisher Scientific
1 Thermofisher Way
Oakwood Village,  OH  44146
Correspondent Contact Dylan Staats
Regulation Number866.1640
Classification Product Code
Subsequent Product Codes
Date Received02/15/2024
Decision Date 05/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No